Systems and methods for medical device a dvancement and rotation

ABSTRACT

A system for moving an elongate medical device has at least one drive element for engaging and moving an elongate medical device. Various embodiments provide for moving the separate inner and outer elements of a telescoping medical device. Some systems also provide for the rotation of a rotatable distal element on a rotatable medical device or the rotation of extension element in a telescoping medical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/138,710 filed on May 3, 2002, which claims priority to U.S.Provisional Patent Application No. 60/288,879, filed May 6, 2001. Thedisclosures of the above applications are incorporated herein byreference in their entirety.

BACKGROUND OF THE INVENTION

A variety of techniques are currently available to physicians forcontrolling elongate medical devices such as catheters, endoscopes andother surgical tools within a patient. For example, magnetic steeringtechniques provide computer-assisted control of a catheter tip whileallowing an operating physician to remain outside the operating roomx-ray field. Thus the physician, freed from having to manually steer thecatheter tip.

However, the physician still must manually advance the device once thedistal end of the device is the desired orientation. A number of medicalprocedures call for more than one elongate medical device to benavigated and positioned within a patient's body. For example, during apercutaneous transluminal coronary angioplasty (PTCA), an“over-the-wire” (OTW) procedure may be performed. A guide wire is placedinto a lumen of an OTW catheter. The two devices are inserted togetherand advanced to the procedure site by successively advancing theguidewire and then the catheter over the guidewire.

In another procedure known as rapid wire exchange (RWE), a guide wire isinserted and navigated to the procedure site. A RWE catheter (also knownas a “monorail” catheter) is placed over the proximal end of the guidewire and is advanced over the wire into the patient. The RWE catheterhas a short guide wire lumen that is open at both ends, thusfacilitating rapid exchange of the catheter with another catheter duringthe procedure.

It is desirable, of course, to minimize physician fatigue and x-rayexposure during a surgical procedure. Advancing one elongate medicaldevice within and/or next to another elongate device, however, isfrequently made difficult by a number of factors, including but notlimited to the lengths and frictional characteristics of the devices.

SUMMARY OF THE INVENTION

In many interventional medical procedures multiple devices are insertedinto a patient's anatomy for diagnosis and therapy. The presentinvention is directed to a motion control mechanism for moving at leastone elongate medical device and addresses the need for computer controlof the motion of multiple devices, either independently or in tandem,when such procedures are performed by robotic or other remotely actuatedmeans. The motion control mechanism can perform the functions of deviceadvancement and retraction, or axial rotation of at least one of thedevices, or any combination of these motions. A computer can controlthese motions in such a manner as to be able to produce a discrete orcontinuous sequence of movements of the various devices in anycombination, if so desired in the medical procedure. An example of sucha sequence in interventional medical procedures is a doddering motioncomprising a rapidly alternating sequence of small advancements andretractions, which could be one method of finding a pathway through anoccluded or partially occluded vessel in a patient, where the devicecould have a straight, curved, or actuated distal tip.

In one embodiment the motion control mechanism comprises an open devicepath bounded on opposite sides by a pair of wheels for drivinglyengaging an elongate medical device in the device path. Morespecifically, the advancer can include a base having a slot with an opentop and opposed sides therein, and a pair of opposed wheels on oppositesides of the slot. A drive mechanism is adapted to be connected to amotor, for turning at least one of the pair of opposed wheels. A covercan be movably mounted on the base for movement between a loadingposition in which the top of the slot is open to allow a portion of theat least one elongate device to be inserted into the slot between thewheels, and a drive position in which the cover at least partiallyblocks the top of the slot to retain the at least one elongate devicetherein. Each wheel can include a circumferential drive member thatengages the at least one device in the slot in the drive position, thedrive member configured to grip but not damage the device in contacttherewith.

In some cases it may be convenient to also axially rotate the medicaldevice(s), either with or without simultaneous advancement, for purposesof navigation and ease of access to particular anatomical regions andlocations. The present invention is directed to also perform such typesof axial rotation maneuvers in addition to advancement and retraction.It is worth noting that the control of device motion could be drivenfrom a microprocessor or other controller that in turn interfaces to acomputer with a Graphical User Interface or other types of user inputsuch as joystick, mouse or customized user input device that directly orindirectly controls device motion. In some situations the computer coulditself decide on the change of lower level control variables required tosuitably move the device, based on high level instructions from a userthat may be defined from any of a variety of user input mechanisms, andapply such control changes. Programmatic sequences of device movementscould also be defined in this manner at a high level by the user, thatwould then be translated by the computer into a set of lower levelcontrol variable changes designed to accomplish the desired objectives.

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the invention, are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a front perspective view of a a first embodiment of a driveunit constructed according to the principles of this invention;

FIG. 2 is a rear perspective view of the drive unit shown in FIG. 1;

FIG. 3 is a front perspective view of the drive unit shown in FIG. 1,with the sliding cover removed;

FIG. 4 is a bottom perspective view of the drive unit shown in FIG. 1,with the bottom removed;

FIG. 5 is a side elevation sectional view of the bottom of the driveunit shown in FIG. 1;

FIG. 6 is a plan sectional view of the inside of the sliding cover ofthe drive unit shown in FIG. 1;

FIG. 7 is a side elevation sectional view of the base of the drive unitshown in FIG. 1;

FIG. 8 is a side elevation sectional view of an embodiment of a wheel ofa drive unit;

FIG. 9 is a plan sectional view of the wheel shown in FIG. 8;

FIG. 10 is a side elevation sectional view of an alternate embodiment ofa wheel of a drive unit;

FIG. 11 is a plan sectional view of an a second preferred embodiment ofan advancer according to the principles of this invention for advancingmultiple devices;

FIG. 12 is a side elevation sectional view of the advancer shown in FIG.11;

FIG. 13 is a front perspective view of an embodiment of a positioningarm useful with the various embodiments of advancers described herein;

FIG. 14 is a side elevation sectional view of a third preferredembodiment of an advancer according to the principles of this inventionfor advancing multiple devices;

FIG. 15 is a plan sectional view of a fourth preferred embodiment of anadvancer according to the principles of this invention for advancingmultiple devices;

FIG. 16 is a top perspective view of a fifth preferred embodiment of anadvancer according to the principles of this invention for performing arapid-wire exchange procedure;

FIG. 17 is a top perspective view of the configuration shown in FIG. 16;

FIG. 18 is a top perspective view of a sixth preferred embodiment of anadvancer according to the principles of this invention for performing anover-the wire procedure;

FIG. 19 is a side elevation sectional view of a seventh preferredembodiment of an advancer in accordance with this invention configuredto engage and turn a y-adapter fitting;

FIG. 20 is a side elevation sectional view of the advancer shown in FIG.19;

FIG. 21 is a front elevation sectional view of the advancer shown inFIG. 19;

FIG. 22 is a front elevation sectional view of the advancer shown inFIG. 19;

FIG. 23 is a side elevation sectional view of the advancer shown in FIG.19;

FIG. 24 is a top perspective view of an eight embodiment of thisinvention, where for simplicity a single device is shown beingcontrolled;

FIG. 25 is a longitudinal cross sectional view of a rotatable catheterin accordance with the principles of this invention;

FIG. 26A is a partial transverse cross sectional view of the catheter inFIG. 25, illustrating a mechanism for the rotation of the rotatableportion;

FIG. 26B is a partial transverse cross sectional view of the catheter inFIG. 26A, after rotation of the rotatable portion;

FIG. 27 is a schematic diagram of a medial device motion system, inaccordance with the principles of this invention shown with a medicaldevice with a rotatable portion;

FIG. 28 is a schematic diagram of a medical device motion system inaccordance with the principles of this invention;

FIG. 29 is a schematic diagram of a medical device motion system inaccordance with the principles of this invention, shown with atelescoping medical device;

FIG. 30 is a schematic diagram of an alternate construction of themedical device motion system shown in FIG. 29, shown with a telescopingmedical device.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses. Reference is made to U.S. patent applicationSer. No. 10/138,710 filed on May 3, 2002, the disclosure of which isincorporated herein by reference in its entirety.

A first embodiment of a drive unit or advancer constructed according tothe principles of this invention is indicated generally as 10 in FIGS. 1through 7. The drive unit or advancer 10 is adapted for moving at leastone elongate medical device such as a catheter and/or guide wire in thebody of a subject. The advancer 30 is preferably small: for example inthis first preferred embodiment it is about 2.6 inches long, about 1.1inches wide (the longitudinal direction), and 1 inch high. The advancer30 is preferably sterile, and is preferably sufficiently inexpensive tobe disposable. The advancer 30 can be positioned close to the site wherean elongate medical device, such as a guide wire or catheter is insertedor introduced into the subject's body (typically the femoral arteryadjacent the patient's groin). The advancer 30 is preferably fabricatedof non-magnetic materials, and more preferably substantially entirely ofnon-metallic materials. For example, the exterior of the advancer 30 canbe made from a strong, durable plastic such as ABS, or other suitablematerial, and the interior components can be made from a strong,dimensionally stable plastic such as Delrin™ or other suitable material.

The advancer 30 is preferably substantially non-magnetic, i.e., it issufficiently non-magnetic that it will not interfere with the operationof a magnetic surgery system that applies fields of 0.5 T or more to theoperating region in a subject to orient the distal tip of the elongatemedical device; that it will not interfere with the operation of amagnetic or other localization system for localizing the position and/ororientation of the distal end of the elongate medical device in theoperating region; and that it will not interfere with magnetic or otherimaging equipment, such as MR imaging equipment. (Of course, when thedrive unit 30 is not used in connection with a magnetic navigationsystem or magnetic resonance imaging system, or magnetic localizationsystem, or when it is used with non-magnetically actuated and steereddevices, the magnetic properties of the drive unit are less important.

The advancer 30 has a front 32, a back 34, a left side 36 and a rightside 38, and comprises a generally curved bottom 40. a base 42 fixedlymounted on the bottom, and a sliding cover 44 slidably mounted over thebase on the bottom. The bottom 40 is curved for convenient mounting onthe surface of the body of the subject—typically on the subject's upperthigh, adajacent the hip where there is convenient access to the femoralartery. However, the drive unit 30 can be mounted on, and used at,different locations. The base 42 is mounted on the bottom 40, forexample with a pair of opposed pins (not shown) that extend throughaligned holes 46 in the base and 48 in the bottom. The pins arepreferably made of a non-magnetic, non-corrosive material such asstainless steel. The sliding cover 44 is movably attached to the bottom40 by a pair of opposed pins (not shown) that extend through a pair ofholes 50 in the cover (shown in FIG. 4) and a pair of horizontal slots52 in the bottom 40 (shown in FIG. 5). Thus the cover 44 can be slidhorizontally relative to the base 22 as limited by the slots 32, asfurther described below.

A slot 54 is formed in the base 42, extending from the front 32 to theback 34 for receiving a portion of an elongate medical device, such as acatheter or guide wire. A hemostasis valve adapter 56 is mounted at thefront end 58 of the slot 54. A sheath or introducer can be connected tothe hemostasis adapter 56, and the elongate medical device can extendthrough the slot 54 and into the sheath or introducer connected to thehemostasis adapter. The hemostasis adapter 56 preferably is flexible andhas an interior surface 60 of Teflon® or other material having acoefficient of friction sufficiently low to permit the medical device toslide freely therein without buckling. The slot 54 in the base 40 iscovered by the sliding cover 44, when the cover 44 is closed as furtherdescribed below.

Opposed wheels 62 and 64 protrude into the slot 54, preferably onopposite sides, to drivingly engage a medical device disposed therein.In this preferred embodiment, wheel 62 is a driven wheel, and wheel 64is an idler wheel. Of course the wheel 64 could be the drive wheel andthe wheel 62 the idler wheel, or both wheels could be drive wheels. Thewheels 62 and 64 may be fabricated in various ways depending, forexample, on the type, material and/or flexibility of the medical deviceto be driven through the drive unit 30. Thus the wheels 62 and 64 may befabricated with small teeth 66 as shown in FIG. 3 (not to scale). Theteeth 66 can grip a catheter as it is driven by the wheels. These smallteeth may have a height of about 0.01 inch. Alternatively, the surfacesof wheels 62 and 64 can be fabricated of a soft material, for example,rubber, such that the wheels would conform to and engage slightly so asnot to crush the medical device being driven by the wheels. In yetanother embodiment, one or both of the wheels 62 and 64 can becircumferentially grooved for engaging an elongate medical device asfurther described below.

The driven wheel 62 is mounted on a shaft 68. The shaft 68 is rotatablymounted about an axis generally perpendicular to the bottom 40, betweena socket 50 in the base 54 (shown in FIG. 3) and a socket 52 in thebottom 40 (shown in FIG. 31). A worm gear 74 is mounted on the shaft 68.A rigid drive shaft 76 is rotatably mounted longitudinally in the base42 and extends through the back 34 of the advancer 30. The drive shaft56 has a worm 58 that engages the worm gear 74 on the shaft 48.

A flexible drive shaft 80 is connected to the rigid drive shaft 56 via aconnector 82, and to a drive motor 84 via a connector 86. The drivemotor 84 is preferably a bi-directional controlled motor, for example, astepper motor, that preferably can be controlled remotely In otherembodiments, the motor 84 can be a servomotor. The flexible drive shaft80 includes a 3/16-inch-diameter flexible coil 68, preferably fabricatedof non-magnetic stainless steel and covered by a flexible clear plastictubing 90. The coil 88 is rotatable by the motor 84 in forward andreverse directions to provide bi-directional movement of the drive wheel62. The flexible drive shaft 80 preferably is sterile for use within asterile operating area. The drive shaft 80 also preferably issufficiently long (for example, approximately four feet long) to allowit to be driven by the motor 84 while the motor remains outside thesterile surgical field. In other embodiments, the motor 84 is alsosterile, is used within the sterile operating area, and is disposed ofafter completion of the operating procedure.

The idler wheel 64 is mounted on a shaft 92 that is snap-fitted into andextending vertically from a slot (not shown) in a floor 94 of the base42. An upper end 96 of the shaft 92 fits in a groove 78 (shown in FIG.32) extending transversely along an inner surface 100 of the slidingcover 44. A spring 102 is stretched, beneath the base floor 94, betweenan edge 104 of the sliding cover 44 and a vertical support 106 of thebase 42. The spring 102 is preferably made of a non-magnetic,non-corrosive material such as stainless steel. The spring force ofspring 102 thus pulls the sliding cover 44 horizontally toward the idlerwheel shaft 92. When the cover 44 is in a closed position, the force ofthe spring 102 causes an end 108 of the groove 98 to press against theshaft upper end 96. The idler wheel 64 thus is pressed against a medicaldevice engaged between the idler wheel 64 and the driver wheel 62.

A generally U-shaped lever arm or handle 90 is used to open the slidingcover 44 relative to the base 42. Two legs 112 of the U-shaped handleare rotatably mounted over two sides 114 of the sliding cover 44 on apair of opposed pivots 116 The pivots 116 extend toward each otherthrough two cams 118. Although not attached to the base 42, each of thecams 118 is limited in its range of motion by an upper shelf 100 in thebase 42. The cover 44 is biased by the spring 102 to a closed positionagainst the shaft upper end 96, the cams are biased in an uprightposition as shown in FIG. 30, and the handle 110 is biased to lie flushagainst the cover 44.

To insert an elongate medical device into the drive unit 30, a userrotates the handle 110 away from the slot 54 in the base 42. As thehandle 110 rotates on the pivots 116, the cams 118 also rotate to lieflat against the bottom 46. The pins extending through the holes 50 andbottom slots 52 move horizontally in the slots 52 away from the slot 54in the base 42. The sliding cover 44 thus is opened sufficiently touncover the slot 54 in the base 42. The groove 98 in the underside ofthe cover 44 allows the cover to be slid open, and subsequently closed,without disturbing the upper end 96 of the idle wheel shaft 92. The cams118 are configured and positioned so as to lock the cover 44 in the openposition.

At least one elongate medical device is loaded into the drive unit 30 bylaying and pressing a length of the device into the slot 54 between theopposed wheels 62 and 64, until the device is engaged by the wheels, forexample, between two grooves in wheels 62 and 64 as previouslydescribed. The user then pivots the handle 110 toward the slot 54,thereby causing the cams to return to the upright position. The slidingcover 44 is pulled by the spring 102 into a closed position over theelongate medical device. When the motor 84 is driven, the rigid driveshaft 56 turns, turning the worm 58, which in turn drives the worm gear54, turning the drive wheel shaft 48 and thus the drive wheel 42. Themedical device is advanced and/or retracted through the adapter 36 andattached sheath.

Another embodiment of wheels 62 and 64 is indicated by reference number130 in FIGS. 8 and 9. The wheel 130 has a central bore 132 configured toreceive a shaft 68 or 91. A circumferential drive member 134 in thewheel 130 is configured to engage one or a plurality of elongate medicaldevices in the slot 54 (shown in FIG. 3) in position to be driven by theadvancer 10. The drive member 134 is configured to grip but not damagean elongate device in contact therewith. In the embodiment shown inFIGS. 8 and 9, the drive member 134 includes a coating 136 on thesurface 138 of the wheel 130. The coating 136 may be, for example,rubber, plastic (e.g., urethane) or silicone or other suitable materialto resiliently engage a medical device.

A cross-sectional view of another embodiment of a wheel that can be usedin the advancer 30 is indicated generally by reference number 150 inFIG. 10. The wheel 150 has a central bore 152 configured to receive ashaft 48 or 72. The wheel 150 also has a circumferential groove 154therein, in which is positioned a circumferential drive member 156. Thedrive member 156 may be solid (and made for example, of rubber, plastic,or silicone), or hollow (and made, for example, of rubber, plastic orsilicone tubing) to provide resilient engagement.

Advancer wheels and drive members may be configured in various ways tofacilitate the driving of a plurality of elongate medical devices pastthe wheels. For example, the wheels and drive members may be configuredto facilitate the selective advancement of one or both of two elongatedevices, where one of the devices is at least partially disposed withinthe other device. For example the medical device could comprise an outermember and an inner member slidably received therein. The outer membermay be moved while the inner member is held stable, for example, byholding or clamping a proximal end of the inner device. Additionally oralternatively, wheels and drive members may be configured to facilitatethe movement of an inner member while an outer device is held stable,for example, by a hand or clamp at a proximal end of the outer member.Advancer wheels and drive members also may be configured to facilitatethe movement of inner and outer devices together. Such combinations ofdevices may be advanced in the body in various ways, as furtherdescribed below.

Referring again to FIGS. 1 through 7, one or both of the wheels 62 and64 are interchangeable with other wheel(s), for example, during amedical procedure by an operating physician. A wheel 62 and/or 64 may beselected for use based on the type(s) and number of elongate devices tobe advanced by the advancer 30. In such manner, a user can use theadvancer 30 to advance, sequentially, more than one device during aprocedure.

The spring 102 also may be interchangeable with another spring during aprocedure. A spring may be selected for use based on the type(s) andnumber of elongate devices to be advanced by the advancer 30, andfurther based on the type(s) of wheels being driven and an amount ofpressure desired to be exerted on the wheels by the spring.

A second preferred embodiment of an advancer in accordance with thisinvention is indicated generally by reference number 200 in FIGS. 11 and12. The advancer 200 is adapted for advancing multiple devices. Theadvancer 200, like advancer 30, is preferably primarily non-magnetic andmore preferably primarily non-metallic. Preferably, the advancer 200 issufficiently non-magnetic and non-metallic that it can be left in placeduring MR imaging. The advancer 200 includes a base plate 204 supportinga plurality, e.g., a pair, of drive units indicated generally as 208.The drive units 208 have a common drive base 212. The base plate 204preferably is about 6.5 inches wide (the transverse direction). Theadvancer 200 is configured to rest on or near a patient in the vicinityof an insertion site and can be mounted on a flexible arm as furtherdescribed below.

The drive base 212 has a plurality, e.g., a pair, of longitudinal slots216, each slot configured to hold at least one elongate medical devicesuch as a catheter or guide wire. Each drive unit 208 also has a slidingcover 220, shown in an open position in FIG. 11. Each sliding cover 220is movably attached to the base plate 204 by a pair of opposed pins (notshown) through a pair of holes (not shown) in the cover 220 and a pairof horizontal slots (not shown) in the drive base 212, such that thecover 220 can be slid horizontally away from and toward a longitudinalaxis 222 of the drive base 212.

A guide base 226 extends distally from the drive base 212. The slots 216extend into the guide base 226 and converge to form a common slot 230 ata distal end 232 of the guide base 226. A hemostasis clamp adapter 234at the distal end 232 of the guide base includes a clamp base 238 andclamp arms 240. The guide base 226 has a cover 244. The advancer 200 ispreferably about 4¾ inches long (between a distal end 246 of thehemostasis adapter 234 and a proximal end 248 of the base plate 204).

One or a plurality of elongate devices can be extended through theadapter 234 as further described below. The adapter 234 preferably isflexible and has an interior surface (not shown) of Teflon® or othermaterial having a coefficient of friction sufficiently low to helpresist buckling of an elongate device moving through the advancer 200.When closed, a cover 220 covers an associated slot 216 and retains anelongate device positioned and/or being driven in the covered slot 216.When closed, the guide base cover 244 covers the common slot 230 andretains an elongate device positioned and/or being driven in the commonslot 230.

A corresponding pair of opposed wheels 250 protrude into each slot 216,which engage one or more medical devices in the slot 216. One of eachpair of wheels 250 preferably is a driven wheel 252 and the other wheelof each pair is an idler wheel 254. The wheels 250 may be fabricated invarious ways, as previously described with reference to the advancer 30,and may have drive members, also as previously described.

Each driven wheel 252 is mounted on a vertically mounted shaft. 256 inthe advancer drive base 212. A worm gear (not shown) is mounted on eachshaft 256. Each drive unit 208 has a rigid drive shaft 258 rotatablymounted longitudinally in the drive base 212 and extending proximallythrough the drive base 212. Each drive shaft 258 has a worm 260 thatengages a corresponding one of the worm gears.

Two flexible drive shafts (not shown) are connected respectively to therigid drive shafts 258 and to two drive motors (not shown). The drivemotors are bi-directional controlled motors, for example, steppermotors, that preferably can be controlled remotely. In otherembodiments, the motors can be servomotors. The flexible drive shaftsand motors may be embodied as previously described in connection withthe advancer 30 (shown in FIGS. 1 through 7).

Each idler wheel 254 is mounted on a shaft 262 snap-fitted into andextending vertically from a slot (not shown) in a floor or drive unitbase 264. An upper end 268 of each shaft 262 fits in a groove (notshown) extending transversely along an inner surface of thecorresponding sliding cover 220. Each of a pair of springs 266 isstretched, beneath the base floor 264, between an edge 270 of acorresponding sliding cover 220 and a vertical support (not shown) ofthe drive base 212. The springs 266 are of a non-magnetic, non-corrosivematerial such as stainless steel. A spring force thus pulls a slidingcover 220 horizontally toward the corresponding idler wheel shaft 262(of course the spring could be arranged to provide a pushing force).When a cover 220 is in a closed position, the force of the correspondingspring 266 causes an end of the groove (not shown) to press against theshaft upper end 268. An idler wheel 254 thus is pressed against one ormore medical devices engaged between the wheel 254 and the opposeddriver wheel 252.

A generally U-shaped lever arm or handle (not shown) is used to open andclose a sliding cover 220 relative to the drive base 212 as previouslydescribed with reference to the advancer 30 (shown in FIGS. 1-7). Twoends of each handle are rotatably mounted over two sides 272 of thecorresponding sliding cover 220 on a pair of opposed pivots (not shown).The pivots further extend toward each other through two cams (notshown). Although not attached to the drive base 212, each of the cams islimited in its range of motion by an upper shelf (not shown) in thedrive base 212. A cover 220 is biased by the corresponding spring 266 ina closed position against the corresponding shaft upper end 262, camsare biased in an upright position (not shown), and the correspondinghandle is biased to lie flush against the cover 220.

To insert an elongate medical device into one of the drive units 208, auser rotates the appropriate handle (not shown) away from thecorresponding slot 216. The corresponding sliding cover 220 thus isopened sufficiently to uncover the slot 216 in the drive base 212. Thegroove (not shown) in the underside of the cover 220 allows the cover tobe slid open, and subsequently closed, without disturbing the upper end268 of the idle wheel shaft 262 of the drive unit 208 being loaded. Thecorresponding cams (not shown) are positioned so as to lock the cover220 in the open position.

At least one elongate medical device is loaded into the appropriatedrive unit 208 by laying and pressing a length of the device into theslot 216 between the opposed wheels 252 and 254, until the device isengaged by the wheels, for example, between two grooves in wheels 252and 254 as previously described with reference to FIGS. 8-10. The userthen presses the appropriate handle toward the slot 216, thereby causingthe appropriate cams to return to the upright position. The slidingcover 220 is pulled by the corresponding spring 266 into a closedposition over the elongate medical device(s). When the correspondingdrive unit motor (not shown) is driven, the corresponding rigid driveshaft 258 turns, turning the corresponding worm 260, which in turndrives the corresponding worm gear (not shown), turning the drive wheelshaft 256 and thus the corresponding drive wheel 252. The medical deviceis driven forward and/or backward in the corresponding slot 216 and thecommon slot 230, and through the adapter 234.

A second drive unit 208 may also be used to drive at least one elongatedevice. The user can load a device in the second drive unit 208, closethe cover 220, and drive the device in the second slot 216. The userthus may use the two drive units 208 to drive a plurality of devicesside by side, and/or with one device at least partly within anotherdevice, through the common slot 230 and through the adapter 234. Theguide body cover 244 can be removed to facilitate the conjoining of twodevices and preferably is replaced to cover the slots 216 and 230 afterthe devices are conjoined. Each of the devices can be drivenindependently of the other (subject to any frictional interactionbetween the devices) via the drive units 208.

A positioning arm for use with the various embodiments of advancersdisclosed herein is indicated generally by reference number 300 in FIG.13. A proximal end 302 of the arm 300 has an attachment device, e.g., aclamp 304, by which the arm 300 is anchorable, for example, to a ceilingor operating table. At least a portion 308 of the arm 300 can be madeflexible for positioning the arm in a desired location. The arm 300 canbe stiffened and locked in position using a lever 310. A shelf 312extends from a ball joint 316 at a distal end 320 of the arm. Anadvancer or other device can be attached to the shelf 312. For example,the advancer base plate 204 (shown in FIGS. 11 and 12) can be screwed tothe shelf 312. The advancer 200 thus can be positioned relative to apatient by moving the arm 300, swiveling the shelf 312 relative to thearm 300, and using the lever 310 to tighten the arm. The advancer 200thus can be positioned above, but not necessarily in contact with, thepatient.

The arm 300 may be fabricated at least primarily of non-magneticstainless steel. In another embodiment, the arm 300 is fabricated atleast primarily of plastic. Where fabricated of stainless steel, the arm300 can be sterilizable and reusable. In one embodiment, thepositionable portion 308 and lever 310 of the arm 300 are similar tothat of known laparoscopic arms. In an embodiment in which the arm 300is fabricated primarily of plastic, the arm can be “snap-locked” into afixed position and may be disposable.

A third preferred embodiment of an advancer in accordance with thisinvention is indicated generally by reference number 350 in FIG. 14. Theadvancer 350 has an upper wheel pair 352 and a lower wheel pair 354. Acatheter 360 is driven by the upper wheel pair 352. A guide wire 362 isdriven by the lower wheel pair 354. The advancer 350 is configured witha y-connector 366 and a guide catheter 368, for example, for use in arapid-wire exchange procedure as further described below.

A fourth preferred embodiment of an advancer in accordance with thisinvention is indicated generally by reference number 400 in FIG. 15. Theadvancer 400 includes a base plate 404 supporting a plurality, e.g., apair, of drive units 408 having a common drive base 412. The advancer400 can be mounted a flexible arm as previously described in connectionwith the advancer 200.

The drive base 412 has a plurality, e.g., a pair, of longitudinal slots416, each slot configured to hold at least one elongate medical devicesuch as a catheter or guide wire. Each drive unit 408 also has a slidingcover 420, shown in an open position in FIG. 15. The sliding covers 420are operable as described with reference to the sliding covers 220(shown in FIGS. 11-12).

A guide base 426 extends distally from the drive base 412. The slots 416extend into the guide base 426 and converge to form a common slot 430 ata distal end of the guide base 226. A hemostasis clamp adapter 434 atthe distal end 432 of the guide base includes a clamp base 438 and clamparms 440. The guide base 426 has a cover 444.

One or a plurality of elongate devices can be extended through theadapter 434, which is configured and operable as described withreference to FIGS. 11 and 12. When closed, a cover 420 covers anassociated slot 416 and retains an elongate device positioned and/orbeing driven in the covered slot 416. When closed, the guide base cover444 covers the common slot 430 and retains an elongate device positionedand/or being driven in the common slot 430.

Protruding into each slot 416 are a corresponding pair of opposed wheels450, which engage one or more medical devices in the slot 416. One ofeach pair of wheels 450 preferably is a driven wheel 452 and the otherwheel of each pair is an idler wheel 454. The wheels 450 may befabricated in various ways, as previously described with reference tothe advancer 10, and may have drive members, also as previouslydescribed.

Each driven wheel 452 is mounted on a vertically mounted shaft 456 inthe advancer drive base 412. Worm gears (not shown) are mounted on eachshaft 456. A drive shaft 458 is mounted longitudinally in the drive base412. The drive shaft 458 includes coaxial distal and proximal sections462 and 464, the distal section 462 extending through the proximalsection 464. Each of the sections has a worm 460 that engages acorresponding one of the worm gears. The worm sections 462 and 464 arerotatably mounted in end sleeves 470 and a middle sleeve 472 attached tothe drive base 412. Rotations of the sections 462 and 464 arefacilitated by bearings 474 in the sleeves 470 and 472. The sections 462and 464 are driven independently of each other via a flexible drivecable 468 having coaxial inner and outer drive shafts (not shown), andtwo drive motors (not shown) connected to the flexible drive cable 468.The drive motors are bi-directional controlled motors, for example,stepper motors, that preferably can be controlled remotely. In otherembodiments, the motors can be servomotors.

Idler wheels 454 are mounted under the sliding covers 420 as describedwith reference to FIGS. 11 and 12. Each of a pair of springs 466 pulls acorresponding sliding cover 420 horizontally to press an idler wheel 454against one or more medical devices engaged between the wheel 454 andthe opposed driver wheel 452, also as described with reference to FIGS.11 and 12.

A lever arm or handle (not shown) is used to open and close a slidingcover 420 relative to the drive base 412, and one or more elongatedevices are inserted in the drive unit(s) 408, as previously describedwith reference to FIGS. 11 and 12. The user may use the two drive units408 to drive a plurality of devices side by side, and/or with one deviceat least partly within another device, through the common slot 430 andthrough the adapter 434. The guide body cover 444 can be removed tofacilitate the conjoining of two devices and preferably is replaced tocover the slots 416 and 430 after the devices are conjoined. Each of thedevices can be driven independently of the other (subject to anyfrictional interaction between the devices) via the drive units 408.

As previously mentioned, the advancer 400 may include two stepper motors(not shown), for example, table-mount SilverMax™ NEMA 17 frame motorsand gear boxes, available from Minarik Corporation of Glendale, Calif.The stepper motors are driven using the flexible drive shaft 468. Onesuitable dual drive shaft is available from Suhner Industrial ProductsCorporation of Rome, Ga.

The multiple-drive advancers 200, 350 and 400 allow top-loading, forexample, of a catheter and a guide wire. One of the elongate devices canbe driven while the other elongate device is held in place. Thus theadvancers 200 and/or 400 can be used, for example, in a “rapid wireexchange” (RWE) procedure in conjunction with a magnetic surgery systemsuch as that described in U.S. patent application Ser. No. 10/138,710incorporated herein by reference. The magnetic system has, for example,a plurality of joysticks and/or a selectable joystick for physicianinterface with one or more medical devices as further described below.

A fifth preferred embodiment of the advancer in accordance with thisinvention for use in a RWE procedure, is indicated generally byreference number 500 in FIGS. 16 and 17. The advancer 500 is attached toa table-mounted flexible and lockable arm 300 (shown in FIG. 13) andpositioned over a patient's leg 504. The leg 504 is restrained. Aproximal end 508 of a guiding catheter 514 is connected to a hemostasisy-connector 510. A proximal end 526 of the y-connector 510 is connectedto the hemostatic valve adapter 434 of the advancer 400.

A distal end (not shown) of the guide catheter 514 is guided, preferablymanually, through an incision 516 into the ostium (not shown) of thepatient. An injection and pressure measurement manifold, indicated byreference number 522, may be connected to a y-port 524 of they-connector 510.

A guidewire 520 is back-loaded (inserted in the distal-to-proximaldirection) into the distal end of a rapid-exchange catheter 518 with aguidewire lumen or “monorail” 532. The proximal end of the guidewireexits the monorail at a location proximal to the point of insertion intothe monorail, albeit distal to the proximal end of the rapid-exchangecatheter, while the distal end of the guidewire is positioned close tothe distal end of the rapid-exchange catheter, either inside or outsidethe latter. The distal end of the rapid-exchange catheter (with theguidewire inside it) is then manually inserted into the guiding catheter514 and the rapid-exchange catheter is manually advanced until theproximal portions of the rapid exchange catheter and the guidewire canbe conveniently inserted into their respective drive units.

The wire 520 and catheter 518 then are next to each other between theguide catheter 514 and the advancer drive units 208. The guide wire iskept in its drive unit 208, and a proximal portion of the catheter 518is inserted into the other drive unit 208. Thus the wire 520 andcatheter 518 can be driven independently and remotely using the advancer400.

The y-connector 510 may be, for example, a Co-Pilot® bleed-back controlvalve, part number 1003331, available from Guidant Corporation ofIndianapolis, Ind. The guide catheter 514 can be, for example, amulti-purpose Guidant catheter in a size 6, 7 or 8F, available fromGuidant Corporation of Indianapolis, Ind. A suitable rapid-wire exchangecatheter 518 is, for example, a balloon micro-catheter, available fromBoston Scientific Corporation, Natick, Mass. A suitable rapid-wireexchange guide wire 520 is, for example, a short-length guide wire.

Another advancer (not shown), for example, the advancer 30, may also bedesirable for driving the guide catheter 514. In embodiments in which aguide catheter advancer is used, the guide catheter advancer would bepositioned and possibly re-positioned during the procedure so as tomaintain an appropriate range of motion relative to a proximal end ofthe guide catheter.

According to a sixth preferred embodiment of the present invention, twoadvancers, e.g., two advancers 30, are used as indicated generally inFIG. 18 by reference number 600, in an over-the-wire (OTW) procedure.Such a procedure may be, for example, a percutaneous transluminalcoronary angioplasty and/or a stent delivery. A distal advancer 604 isused to advance a balloon catheter 606. A proximal advancer 608 is usedfor driving a guide wire 612. A guide catheter 616 is attached via aluer fitting 620 to a y-connector 624. The catheter advancer 604 isconnected to a proximal end 626 of the y-connector 624. The ballooncatheter 606 has an inflation lumen 628 through which the balloon can beinflated or a stent can be delivered.

The guide wire 612 is inserted into a guide wire lumen (not shown) ofthe balloon catheter 606. The guide wire 612 and balloon catheter 606are driven together by the catheter advancer 604 through the guidecatheter 616 into place within the patient. When it is desired to drivethe guide wire 612 independently of the balloon catheter 606, theproximal end 634 of the balloon catheter 606 is held stable while theguide wire 612 is inserted into and driven by the wire advancer 608. Theguide wire 612 thus can be driven backward relative to the catheter 606during loading and advancement of the catheter 606.

A seventh preferred embodiment of an advancer in accordance with thisinvention is indicated generally by reference number 700 in FIGS. 19through 23. The advancer 700 is configured to open and/or close aTouhy-Borst fitting 704 that connects a y-adapter 708 to the advancer700. The advancer 700 has a body 712 with a slot 714. The advancer 700is used to drive a catheter 718 through the slot 714 and the y-adapter708. A drive gear assembly 722 that includes a drive shaft 720 and anidler wheel 724 is configured to drive the catheter 718. The catheter718 extends through a y-adapter connector 728 that is connected to theTouhy-Borst fitting 704, fits in the slot 714 and is rotatable about thecatheter 718.

A contact gear 732 that can contact the y-adapter connector 728 isconfigured to engage a rotator drive wheel 736. The gear 732 is normallynot engaged with the wheel 736, which can rotate with the drive shaft720. The wheel 736 rotates whenever the driveshaft 720 is active. Whenit is desired to tighten or loosen the Touhy-Borst fitting, aspring-loaded engagement switch 740 is activated, or alternatively anengagement lever 744 is manually activated, to cause the gear 732 tomove, along an engagement guide 746, into engagement with the y-adapterconnector 728. The engagement switch 740 can be activated using, forexample, an electromechanical or hydraulic linear switch or activator748. Thus the gear 732 can be engaged and disengaged by a remote user.The gear 732 is configured so as not to over-tighten the Touhy-Borstfitting.

The foregoing advancer 700 allows the Touhy-Borst fitting on they-adapter to be opened and/or closed remotely. Thus the need for thefitting to be operated manually during a medical procedure, for example,during an interventional cardiology (IC) procedure, is reduced oreliminated.

Yet another embodiment is shown in FIG. 24. In this embodiment, theelongate medical device can be advanced by rotation of the distal pairof wheels 915 and 917, as well as rotated about its long axis by meansof a geared sleeve that tightly engages the device for rotationalpurposes while at the same time permitting advancement and retraction ofthe device. For simplicity, this figure shows an advancer unit 900engaging a single device 901. In addition to a drive cable 905, gearmechanisms 906 and advancement drive wheels 915 and 917, there is asecond drive cable 903 that is connected to a gearbox unit 908, which inturn connects to a geared drive wheel 910. A geared sleeve 912 issandwiched between the geared drive wheel 910 and a geared idle wheel909. The medical device passes through the geared sleeve 912 and rotateswith it as the flexible drive cable 903 rotates. This allows fortransmission of the axial rotation to the distal end of the device,which could have a curved or bent shape, or a sharper angulation. Thisbent distal shape could itself be actuated by means of other actuationmechanisms such as cables passing within the device, small servo motors,external magnetic fields, electrostriction, hydraulic action, or avariety of other mechanisms known to those skilled in the art, so thatthe angular change in orientation over the distal portion iscontrollable. As the geared sleeve rotates, the shaped distal end alsorotates and may be suitably directed within a patient's anatomy. Forinstance, if entry is desired into a particular vessel branch within theanatomy, the distal tip may be directed to assume a suitably convenientorientation in the manner described here. This orientation in some casescould then make the navigation of a second device such as a guidewiremore convenient.

In one mode of operation, the drive cables can be driven so as to causerapid alternating advancement and retraction movements of the medicaldevice. Such a “doddering” mode can sometimes be useful for instance infinding a pathway through an occluded vessel, either with or withoutother conjunctive actuation of the distal tip of the device. In anotheroperational mode, the gear arrangements can be configured to produce amechanical vibration of the device, which can also be useful for somemedical applications, for example to reduce or overcome friction.

It is possible to use a multiple device motion control mechanism asdescribed herein to position and suitably orient the distal tip of anouter device, which then provides a pathway for an inner device to bepassed within it and emerge from the distal end of the outer device toaccess or gain entry into a desired anatomical region within a patient.The converse arrangement, where an inner device is held fixed while anouter device is advanced over it to suitably access an anatomicalregion, can also be used in other situations. In some cases one of thedevices can be manually advanced, while in others various combinationsof manual and computerized motion control of the device can be employed.Likewise axial rotation of one or more of the devices could be manual ormotor-driven.

It should be noted that the advancement and rotation of the medicaldevice, doddering motions and extent of vibration could be controlledfrom a microprocessor or other control unit that can be interfaced to acontrol computer. The computer can have a variety of input modalitiesfor a user to control the motion of operational mode of the medicaldevice at a high level, such as a mouse, joystick or other forms ofcustomized input device. The control unit can convert high-level userinstructions into the control variables that actually define the desireddevice movements at a lower level. The computer can also drive otheractuation modes such as magnetic field, cable lengths, servo motors,electrostrictive controls, hydraulic or other modes known to thoseskilled in the art that control the distal tip of the device so that thedevice can be suitably navigated to desired parts of the anatomy.Sequences of moves of different types can also be applied to the deviceunder computer control.

The description of the invention is merely exemplary in nature and,thus, variations that do not depart from the gist of the invention areintended to be within the scope of the invention. Such variations arenot to be regarded as a departure from the spirit and scope of theinvention.

An embodiment of a rotatable catheter adapted for use with the variousembodiments of motion control systems of the present invention isindicated generally as 1000 in FIG. 25. As shown in FIG. 25, thecatheter 1000 comprises a proximal portion 1002 and a distal portion1004. The proximal portion 1002 is preferably elongate and flexible. Thedistal portion 1004 can be generally straight, as shown, or it can has apreformed shape, such as a bend or a curve, so that rotation of thedistal portion 1004, as described below, changes the position andorientation of the distal end of the catheter 1000. The distal end ofthe proximal portion 1002 and the proximal end of the distal portion1004 are configured to interfit so that the distal end portion 1004 canrotate freely with respect to the proximal end portion, but is securelyretained thereon. Of course, the distal portion 1004 could be mounted onthe proximal portion in some other way, provided that the distal portion1004 is freely rotatable yet securely retained on the proximal portion1002.

A control element 1006 extends from the distal portion 1004, through alumen 1008 in the proximal portion 1002. The control element 1006 ispreferably flexible, but torsionally stable, so that rotation of thecontrol element 1006 rotates the distal portion 1004. The controlelement 1006 may be sufficiently long to extend from the proximal end ofthe proximal portion 1004, where it can be conveniently rotated to causethe distal portion 1004 to rotate. Alternatively, the control element1006 may be shaped with corners or a flat sides so that the controlelement 1005 can be engaged and turned through the wall 1010 of theproximal portion 1002. For example, the control element 1006 can beengaged by rollers 1012 and 1014 that compress the wall 1010 of theproximal portion 1002. As illustrated in FIGS. 26A and 26B, as therollers 1012 and 1014 revolve around the longitudinal axis of thecatheter 1000, the rollers can rotate around their respective axes,rolling over the surface of the wall 1010 while urging the controlelement 1006 to rotate within the lumen 1008. Alternatively, the rollers1012 and 1014 can slide over the surface of the wall 1010, as theyrevolve around the proximal portion 1002 and rotate the control element1006.

The rotatable catheter 1000 can form part of a medical device andmedical device motion system combination as shown schematically as 1020in FIG. 27. The combination 1020 comprises an elongate medical device,such as rotatable catheter 1000, and a medical device motion system1022. The medical device motion system 1022 comprises at least one driveelement, such as drive wheel 1024. In some embodiments, the medicaldevice motion system 1022 further comprises a second wheel, which can bea drive wheel or a driven wheel, and in other embodiments the medicaldevice motion system further comprises a smooth support 1026, alongwhich the catheter 1000 can freely slide. The medical device motionsystem 1022 also comprises rollers, such as 1012 and 1014, which canrevolve around the axis of the catheter 1000, to a rotate controlelement 1006 extending through lumen 1008 in the proximal portion 1002,and thus rotate the distal portion 1004.

An alternative embodiment of the medical device motion system 1022 isindicated generally as 1028 in FIG. 28. The medical device motion system1028 can be used to advance an elongate medical device, such as aconventional catheter 1030. The medical device motion system 1028comprises at least one drive element, such as drive wheel 1032. In someembodiments, the medical device motion system 1028 further comprises asecond wheel, which can be a drive wheel or a driven wheel, and in otherembodiments the medical device motion system further comprises a smoothsupport 1034, along which the catheter 1030 can freely slide. Themedical device motion system 1028 also comprises at least one rotationaldrive element, such as a drive wheel 1036, which engages and rotates thecatheter 1030 about its longitudinal axis. The medical device motionsystem 1028 can also include a second wheel 1038, which can engage thecatheter 1030. The second wheel 1038 can be a driven wheel, or an idlerwheel. Thus the system 1028 can used to advance and retract a device,such as catheter 103, and to rotate a device such as catheter 1030,either clockwise or counterclockwise.

Another embodiment of a medical device and medical device motion systemcombination is shown schematically as 1050 in FIG. 29. The combination1050 comprises a telescoping catheter 1052, and first and second medicaldevice motion systems 1054 and 1056. The telescoping catheter 1052comprises an outer sheath member 1058, having a proximal end 1060, adistal end 1062, and a lumen therebetween. The telescoping catheterfurther comprises an inner member 1064, having a proximal end 1066, anda distal end 1068, slidably received in the lumen of the outer sheath1058, and telescopable from the distal end 1062 of the outer sheath1058. The section of the inner member 1064 adjacent the distal end 1068can have a preformed configuration such as a bent or curvedconfiguration (shown in FIG. 30), or the distal end could have astraight or shapeless configuration (shown in FIG. 29). The combination1050 preferably also includes a first medical device motion system 1054comprising at least one drive element, such as drive wheel 1070. In someembodiments, the medical device motion system 1050 further comprises asecond wheel, which can be a drive wheel or a driven wheel, and in otherembodiments the medical device motion system further comprises a smoothsupport 1072, along which the outer sheath 1058 can freely slide. Themedical device motion system 1054 also comprises rollers, such as 1074and 1076, which can revolve around the axis of the catheter 1052, torotate inner member 1064 in the outer member 1058. The combination 1050further includes a second medical device motion system 1056, whichcomprises at least one drive element, such as drive wheel 1078. In someembodiments, the second medical device motion system 1050 furthercomprises a second wheel, which can be a drive wheel or a driven wheel,and in other embodiments the medical device motion system furthercomprises a smooth support 1080, along which the inner element 1064 canfreely slide.

The driver in system 1054 (wheel 1070 in the preferred embodiment)preferably engages the outer sheath 1058 sufficiently to cause the outersheath 1058 to frictionally engage the inner member 1064, so that thedriver can drive both the outer sheath 1058 and the inner member 1064.The driver in system 1056 (wheel 1078 in the preferred embodiment)preferably engages the inner member 1064 sufficiently to overcome thefriction between the inner member 1064 and the outer sheath 1058, todrive the inner member 1064 independently of outer sheath 1058. When itis desired to drive the inner member 1064 and the outer sheath 1058together, both the systems 1054 and 1056 can be used together, or thesystem 1056 can be disengaged so that it does not impair the movement ofthe inner member 1064. When it is desired to drive the inner member 1064alone, the system 1056 can be operated alone, and the system 1054 helpsretain the outer sheath 1058 in its position.

Another embodiment of a medical device and medical device motion systemcombination is shown schematically as 1090 in FIG. 30. The combination1090 comprises a telescoping catheter 1092, and first and second medicaldevice motion systems 1094 and 1096, respectively. The telescopingcatheter 1092 comprises an outer sheath member 1098, having a proximalend 1100, a distal end 1102, and a lumen therebetween. The telescopingcatheter 1092 further comprises an inner member 1104, having a proximalend 1106, and a distal end 1108, slidably received in the lumen of theouter sheath 1098, and telescopable from the distal end 1102 of theouter sheath 1098. The section of the inner member 1104 adjacent thedistal end 1108 can have a preformed configuration such as a bent orcurved configuration (shown in FIG. 30), or the distal end could have astraight or shapeless configuration (shown in FIG. 29). The firstmedical device motion system 1094 comprises at least one drive element,such as drive wheel 1110. In some embodiments, the medical device motionsystem 1094 further comprises a second wheel, which can be a drive wheelor a driven wheel, and in other embodiments the medical device motionsystem further comprises a smooth support 1112, along which the outersheath member 1098 can freely slide. The combination 1090 furtherincludes a second medical device motion system 1096, which comprises atleast one drive element, such as drive wheel 1114. In some embodiments,the second medical device motion system 1096 further comprises a secondwheel, which can be a drive wheel or a driven wheel, and in otherembodiments the medical device motion system further comprises a smoothsupport 1116, along which the inner element 1104 can freely slide. Themedical device motion system 1096 also comprises at least one driveroller, and in this preferred embodiment a pair of opposed rollers 1118and 1120 to rotate the inner member 1104 in the outer member 1098.

1. An advancer for moving at least one elongate medical device, theadvancer comprising: a base having a slot with an open top and opposedsides therein; a pair of opposed wheels on opposite sides of the slot; adrive mechanism adapted to be connected to a motor, for turning at leastone of the pair of opposed wheels; and a cover movably mounted on thebase for movement between a loading position in which the top of theslot is open to allow a portion of the at least one elongate device tobe inserted into the slot between the wheels, and a drive position inwhich the cover at least partially blocks the top of the slot to retainthe at least one elongate device therein; each wheel comprising acircumferential drive member that engages the at least one device in theslot in the drive position, the drive member configured to grip but notdamage the device in contact therewith.
 2. The advancer of claim 1wherein at least one of the drive members comprises a plurality ofserrations.
 3. The advancer of claim 1 wherein at least one of the drivemembers comprises a coating on the wheel.
 4. The advancer of claim 1wherein at least one of the drive members comprises tubing extendingaround the wheel.
 5. The advancer of claim 1 wherein at least one of thedrive members comprises at least one of rubber, plastic and urethane. 6.The advancer of claim 1 wherein at least one of the drive members isreplaceable by another drive member during a medical procedure.
 7. Theadvancer of claim 1 wherein at least one of the wheels is replaceable byanother wheel during a medical procedure.
 8. The advancer of claim 1wherein a plurality of elongate medical devices are inserted into theslot, the drive members configured to allow a first of the devices to bedriven while allowing a second of the devices not to be driven.
 9. Theadvancer of claim 8 wherein the first device is at least partiallyinside the second device.
 10. The advancer of claim 8 wherein the seconddevice is held at its proximal end while the first device is beingdriven.
 11. The advancer of claim 8 wherein each of the first and seconddevices is selectively driven by a user remote from the advancer. 12.The advancer of claim 1 further comprising a spring that, when the coveris in the drive position, pulls one of the wheels against the at leastone elongate device in the slot and toward the other wheel so as toprovide a pressure by the wheels against the device; and wherein thespring is replaceable by another spring during a medical procedure. 13.The advancer of claim 1 further comprising a fitting for a hemostasisvalve adapter, the drive mechanism further comprising: a drive shaft fordriving at least one wheel of the wheel pair; an adapter engagementwheel mounted the drive shaft; and an adapter engagement gear configuredto engage and turn a valve adapter in the fitting when turned by theadapter engagement wheel.
 14. The advancer of claim 1 wherein the slotfurther comprises a plurality of slots and the pair of opposed wheelscomprises a plurality of pairs, each pair of wheels on opposite sides ofa corresponding slot, the drive mechanism adapted for turning at leastone of each pair of opposed wheels.
 15. The advancer of claim 14 whereinthe drive mechanism comprises a coaxial drive cable connected to aplurality of motors, the at least one of each pair of opposed wheelsdriven by a corresponding motor.
 16. An advancer for moving at least oneelongate medical device, the advancer comprising: a drive base having aplurality of slots, each slot having an open top and opposed sidestherein; a plurality of pairs of opposed wheels, each pair on oppositesides of a corresponding slot; a drive mechanism configured forconnection to a plurality of motors, each motor configured to turn atleast one wheel of a corresponding pair of opposed wheels; and for eachpair of wheels, a cover movably mounted on the drive base for movementbetween a loading position in which the top of a slot is open to allow aportion of at least one elongate device to be inserted into the openslot between the corresponding pair of wheels, and a drive position inwhich the cover at least partially blocks the top of a slot to retain atleast one elongate device therein.
 17. The advancer of claim 16 furthercomprising a guide base extending distally from the drive base and inwhich at least two of the slots converge to form a common slot.
 18. Theadvancer of claim 17 further comprising: a hemostasis valve adapterattached to the guide base and aligned with the common slot for passagetherethrough of at least one elongate device.
 19. The advancer of claim16 further comprising a guide base cover configured to retain at leastone elongate device in the common slot.
 20. The advancer of claim 16wherein a wheel comprises a circumferential drive member that is pressedagainst at least one elongate device in a slot in the drive position,the drive member configured to hold but not damage the elongate devicein contact therewith.
 21. The advancer of claim 16 wherein the drivemechanism comprises a coaxial drive cable and a worm shaft connectableto the drive cable and having a plurality of sections, each sectionoperable by a corresponding one of the plurality of motors, via thedrive cable, to turn at least one wheel of a corresponding pair ofopposed wheels.
 22. A device motion control mechanism for moving atleast one elongate medical device, the mechanism comprising: a drivebase having a plurality of slots, each slot having an open top andopposed sides therein; a first plurality of pairs of opposed wheels,each pair on opposite sides of a corresponding slot; a drive mechanismconfigured for connection to a plurality of motors, each motorconfigured to turn at least one wheel of a corresponding pair of opposedwheels; a rotary sleeve into which the device may pass for tightengagement with the sleeve, which sleeve together with device may beaxially rotated by means of engagement with a second plurality ofopposed wheels, and for each first pair of wheels, a cover movablymounted on the drive base for movement between a loading position inwhich the top of a slot is open to allow a portion of at least oneelongate device to be inserted into the open slot between thecorresponding pair of wheels, and a drive position in which the cover atleast partially blocks the top of a slot to retain at least one elongatedevice therein.
 23. The device motion control mechanism of claim 22further comprising a guide base extending distally from the drive baseand in which at least two of the slots converge to form a common slot.24. The device motion control mechanism of claim 22 further comprising:a hemostasis valve adapter attached to the guide base and aligned withthe common slot for passage therethrough of at least one elongatedevice.
 25. A device motion control system for moving at least oneelongate medical device within a body, the system comprising: anadvancer and axial rotation mechanism having a drive base with aplurality of slots, each slot having an open top and a pair of opposedwheels on opposed sides of the slot, each wheel pair, when in a driveposition, configured to engage at least one elongate device placedlengthwise in the slot; a plurality of motors connected to the advancerand axial rotation mechanism, each motor configured to turn at least onewheel of a corresponding wheel pair; and a user-operable control systemconfigured to control the motors.
 26. The advancer system of claim 16further comprising a flexible arm having a proximal end anchorable to ananchoring location, and a distal end connectable to the advancer, thearm configured to allow the advancer to be adjustably positionedrelative to a patient, the arm further configured to be locked in adesired position.
 27. The advancer system of claim 16 further comprisinga flexible coaxial drive cable having a plurality of coaxial drivemembers connecting the motors to the advancer, each drive memberoperable to drive a corresponding wheel pair.
 28. The advancer system ofclaim 16 wherein the control system is operable by a user remote from asite in which the body is positioned.
 29. The advancer system of claim16 wherein the control system is operable by a user to drive a pluralityof elongate devices independently of one another.
 30. The device motioncontrol system of claim 25, where said control system controls thedevice motion so as to produce a doddering motion of the devicecomprising rapid alternation of small advancements and retractions. 31.A device motion control system for moving at least one elongate medicaldevice within a body, the system comprising: an advancer and axialrotation mechanism having a drive base with a plurality of slots, eachslot having an open top and a pair of opposed wheels on opposed sides ofthe slot, each wheel pair, when in a drive position, configured toengage at least one elongate device placed lengthwise in the slot; aplurality of motors connected to the advancer and axial rotationmechanism, each motor configured to turn at least one wheel of acorresponding wheel pair; a low-level electronic control systemconfigured to control the motors; a computer that controls the low-levelelectronic control system, said computer being capable of translatinguser-defined high-level commands into low-level controls of actualdevice motion.
 32. The device motion control system of claim 31, wheresaid computer controls the device motion so as to produce a dodderingmotion of the device comprising rapid alternation of small advancementsand retractions.
 33. The device motion control system of claim 31, wheresaid computer programmatically controls the device motion so as toproduce a sequence of device movements.
 34. An advancer for moving atleast one elongate medical device, the advancer comprising: a basehaving a slot with an open top and opposed sides therein; a pair ofopposed wheels on opposite sides of the slot; a drive shaft operable bya motor to drive at least one of the pair of opposed wheels; a slotcover movable between a loading position in which the top of the slot isopen to allow a portion of the at least one elongate device to beinserted into the slot between the wheels, and a drive position in whichthe cover at least partially covers the top of the slot; a hemostasisvalve adapter fitting at an end of the slot; an adapter engagement wheelmounted on the drive shaft; and an adapter engagement gear configured toengage and turn a valve adapter in the fitting when turned by theadapter engagement wheel.
 35. The advancer of claim 34 furthercomprising an engagement device configured to cause the adapterengagement wheel to alternately engage and disengage the adapterengagement gear relative to the fitting.
 36. The advancer of claim 34wherein the engagement device comprises a remotely operable switch. 37.A method of moving a plurality of elongate medical devices havingproximal and distal ends, the method comprising: inserting a portion ofa first elongate device lengthwise into a first slot in a base of anadvancer and between a first opposed pair of wheels; inserting a portionof a second elongate device lengthwise into a second slot in the base ofthe advancer and between a second opposed pair of wheels; engaging thefirst device between the first wheel pair and the second device betweenthe second wheel pair; and selectively turning at least one wheel of atleast one of the wheel pairs to move at least one of the devices. 38.The method of claim 37 further comprising: opening a seal of ahemostasis valve on a distal end of the advancer; passing a distal endof at least one of the elongate devices into the valve; and closing theseal.
 39. A method of moving a plurality of elongate medical deviceshaving proximal and distal ends, the method comprising: inserting aportion of a first elongate device lengthwise into a slot in a base of afirst advancer and between a first opposed pair of wheels; inserting aportion of a second elongate device lengthwise into a slot in a base ofa second advancer and between a second opposed pair of wheels; engagingthe first device between the first wheel pair and the second devicebetween the second wheel pair; and selectively turning at least onewheel of at least one of the wheel pairs to cause elongate movement ofat least one of the devices.
 40. The method of claim 39 where a portionof at least one of the first or second elongate device passes throughand engages a rotary sleeve.
 41. The method of claim 40 where at leastone medical device is selectively axially rotated by rotating theengaging rotary sleeve.
 42. The method of claim 41, where at least oneaxial rotation or elongate movement is computer-controlled.
 43. Themethod of claim 41, where at least one of the advancement or axialrotation engagements may be disengaged.
 44. The method of claim 43 wherethe motion of the device is computer-controlled through control of theremaining engagements.
 45. A method of advancing a guide wire and acatheter in a body comprising: connecting a Y-adapter between ahemostasis valve fitting of an advancer and a proximal end of a guidingcatheter positioned in the body; inserting a portion of the guide wirelengthwise into a first slot and common slot of the advancer andinserting a distal end of the guide wire through the Y-adapter into theguiding catheter; closing the first slot and using the advancer to drivethe guide wire relative to the guiding catheter and into a desiredposition; placing a monorail of a rapid-exchange catheter over aproximal end of the guide wire; opening the first slot and manuallyadvancing the monorail along the guide wire until a distal end of themonorail reaches the guide catheter; inserting a portion of the catheterlengthwise into a second slot of the advancer; and using the advancer toindependently and selectively drive the guide wire and the catheter. 46.The method of claim 40 further comprising inserting a tube stiffenerover the guide wire between the advancer and the Y-adapter.
 47. A methodof advancing a guide wire and a balloon catheter in a body comprising:connecting a Y-adapter between a hemostasis valve fitting of a distaladvancer and a proximal end of a guiding catheter positioned in thebody; inserting the guide wire into a guide wire lumen of the ballooncatheter; inserting a portion of the guide wire and balloon catheterlengthwise into a slot of the distal advancer and inserting a distal endof the guide wire and balloon catheter through the Y-adapter into theguiding catheter; using the distal advancer to drive the guide wire andballoon catheter relative to the guiding catheter and into a desiredposition; holding a proximal end of the balloon catheter stable whileinserting a proximal portion of the guide wire lengthwise into a slot ofa proximal advancer; and using the proximal advancer to independentlyand selectively drive the guide wire.
 48. The method of claim 42 furthercomprising driving the guide wire backward relative to the ballooncatheter.
 49. An advancer for independently advancing and retracting theinner and outer members of a telescoping catheter in which the innermember is slidably disposed inside the outer member, the advancercomprising a first pair of wheels for engaging and driving the outermember between them, the first pair of wheels compressing the outermember to engage and simultaneously drive the inner member with theouter member, and a second pair of wheels for engaging and driving theinner member, the second pair of wheels engaging and driving the innermember sufficiently to overcome the frictional engagement between theinner and outer members, without overcoming the frictional engagementbetween the outer member and the first pair of wheels.
 50. A telescopingmedical device and driver combination, the telescoping medical devicecomprising an outer sheath and an inner core slidably disposed in theouter sheath and telescopable from the distal end thereof, and thedriver comprising a first drive that compressibly engages the outersheath sufficiently to cause the outer sheath to frictionally engage theinner core therein to drive the inner core and outer sheath together,and a second drive that engages the inner core sufficiently to drive theinner core to overcome the inner and outer core without overcoming thecompressible engagement between the first drive and the outer sheath.51. The combination of claim 50, where the distal portion of at leastone of outer sheath or inner core may be actuated under computercontrol.
 52. The combination of claim 51, where at least one of outersheath or inner core may be axially rotated.
 53. The combination ofclaim 51, where at least one of the first or second drives iscomputer-controlled.
 54. The combination of claim 52, where the axialrotation is computer-controlled.
 55. A method of selectively driving atelescoping medical device comprising an outer sheath and an inner coreslidably disposed in the outer sheath and telescopable from the distalend thereof, the method comprising: compressibly engaging the outersheath with a first driver sufficient to cause the outer sheath tofrictionally engage the inner core therein, and selectivelysimultaneously driving the inner core and the outer sheath so engaged;engaging the inner core with a second driver sufficiently to separatelydrive the inner core by overcoming the frictional engagement between theinner core and outer sheath; and separately driving the inner core withthe second driver.
 56. A method of selectively driving a telescopingmedical device comprising an outer sheath and an inner core slidablydisposed in the outer sheath and telescopable from the distal endthereof, the method comprising: compressibly engaging the outer sheathwith a first driver sufficient to cause the outer sheath to frictionallyengage the inner core therein, and selectively simultaneously drivingthe inner core and the outer sheath so engaged; engaging the inner corewith a second driver sufficiently to separately drive the inner core byovercoming the frictional engagement between the inner core and outersheath without overcoming the compressible engagement between the firstdriver and the outer sheath; and separately driving he inner core withthe second driver.
 57. A method of selectively driving a telescopingmedical device comprising an outer sheath and an inner core slidablydisposed in the outer sheath and telescopable from the distal endthereof, the method comprising: engaging the outer sheath with a firstdriver engaging the inner core with a second driver, operating the firstand second drivers to drive the inner core and the outer sheath, andoperating only the second driver to drive only the inner core.
 58. Themethod of claim 48, where the operation of at least one of first orsecond drivers is computer controlled.